JPH10118005A - Guide wire - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a guide wire which allows gradual change in rigidity at a wire connection part with excellent operability and resistance to kinking in a type produced by connecting wires with a different rigidity. SOLUTION: A wire body of a guide wire 1 comprises a first wire A and a second wire B with a different rigidity and the first wire A and the second wire B are connected by a tubular connection member 12. A slit is formed in a part 121 to be wrapped of a joint member 12 wrapping the first wire A and the pitch thereof is so formed to be closer toward the side of the first wire A. The arranging of such a slit enables gradual increase in the rigidity of the connection member 12 of the guide wire 1 to the side of the second wire B from the side of the first wire A.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a guidewire, and more particularly, to a guidewire having a function of guiding a catheter or the like to a target site in a living body.

[0002]

2. Description of the Related Art A guide wire is used for treatment and examination for the purpose of minimally invasive to a site where surgery is difficult or a human body, for example, PTCA (Percutaneous Transluminal Coronary).
Angioplasty (percutaneous coronary angioplasty) is used for guiding a catheter. Among these, the guide wire used in PTCA operation is inserted into the catheter prior to insertion of the catheter into the blood vessel, and the distal end of the guide wire is moved together with the catheter so that the distal end of the guide wire is located near the target blood vessel stenosis. Used to guide up to. The distal end of this catheter has various shapes depending on the purpose and site of use, and has flexibility that can follow complicated bending in blood vessels and the body.

Accordingly, a guide wire used for inserting such a catheter into a blood vessel and a body has a moderate flexibility, a pushability for transmitting an operation at hand at a proximal end to a distal end, and a torque transmission. Properties (collectively referred to as “operability”), kink resistance (bending resistance), and the like are required. Among these characteristics, as a structure for obtaining a moderate flexibility, a structure provided with a flexible metal coil around a thin tip core material of a guidewire, or a superstructure such as nitinol is used as a guidewire core material. Some use elastic wires.

In a conventional guide wire, the core material is substantially one.
It is made of various materials, and a relatively rigid material is used in order to enhance the operability of the guidewire, and as a result, the flexibility of the distal end portion of the guidewire is lost. In addition, if a material having relatively low rigidity is used to obtain the flexibility of the distal end portion of the guide wire, the operability at the proximal end portion of the guide wire is lost. Thus, it has been difficult to satisfy the required flexibility and operability with one kind of core material.

[0005] In order to improve such a defect, for example, a Ni-Ti alloy wire is used as a core material, and a heat treatment is performed under different conditions on a tip end portion and a base end portion thereof to enhance the flexibility of the tip end portion.
There has been proposed a guide wire having an increased rigidity at the base end.
However, there is a limit in controlling the flexibility by such heat treatment, and even if sufficient flexibility is obtained at the distal end, satisfactory rigidity may not always be obtained at the proximal end.

Further, in order to satisfy the flexibility at the distal end and the high rigidity at the proximal end, a guide wire connecting a Ni-Ti alloy wire and a stainless steel wire using a Ni-Ti alloy tubular connecting member. Is disclosed in JP-A-4-9162. Since the overall rigidity of the tubular connecting member of the Ni—Ti alloy wire used here is uniform, N
A relatively large difference in rigidity occurs at the connection point between the i-Ti alloy wire and the stainless steel wire.

[0007] A stress concentration occurs in a portion where such a difference in rigidity occurs, which causes kink or lowers operability.

[0008]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a guide wire having excellent operability and kink resistance by providing continuity in the change in rigidity in the longitudinal direction of the wire.

[0009]

This and other objects are achieved by the present invention which is defined below as (1) to (7).

(1) A flexible first wire disposed on the distal end side, and a second wire disposed on the proximal end side of the first wire and having greater rigidity than the first wire. And a tubular connection member for connecting the first wire and the second wire, wherein the connection member comprises the first wire
A groove and / or a slit formed at a position on the distal end side of a boundary between the second wire and the second wire.

(2) A first flexible wire disposed on the distal end side, and a second wire disposed on the proximal end side of the first wire and having greater rigidity than the first wire. And a tubular connection member for connecting the first wire and the second wire, wherein the connection member comprises the first wire
A groove and / or a slit is formed at a position on the distal side from the boundary between the second wire and the second wire, and the rigidity near the base end of the first wire is continuously increased in the longitudinal direction of the wire. A guidewire configured to change.

(3) The guide wire according to the above (1) or (2), wherein the groove and / or the slit are formed so as to be denser toward a distal end of the connection member.

(4) The second wire is made of a metal material, and the connecting member is made of the same or similar material as the second wire. The guidewire according to any one of the above.

(5) The guide wire according to (4), wherein the first wire is made of a superelastic metal, and the second wire is made of stainless steel.

(6) The first wire and the connection member, and the second wire and the connection member are fixed to each other by welding, according to any one of the above (1) to (5). Guide wire.

(7) The connection end face between the first wire and the second wire is inclined at a predetermined angle with respect to a plane normal to the axis of both wires (1). The guidewire according to any one of (6) to (6).

[0017]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a guide wire according to the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

FIG. 1 is an overall side view of a guide wire according to the present invention. The guide wire 1 of the present invention
And a wire main body (core wire) mainly composed of This wire main body includes a first wire A disposed on the distal end side thereof.
And a second wire B disposed on the proximal end side of the wire main body. The proximal end of the first wire A and the second wire B
Is covered and connected by a tubular connecting member 12.

The first wire A is a wire having flexibility, and its constituent material is not particularly limited. For example, various plastics and various metals can be used.
Preferably, it is made of a superelastic alloy. Thereby, the distal end of the wire main body having excellent operability and kink resistance can be obtained without increasing the diameter of the first wire A.

Here, the superelastic alloy is generally called a shape memory alloy, and refers to an alloy which exhibits superelasticity at a use temperature.
Superelasticity refers to the property of recovering almost the original shape even when deformed (bent, pulled, compressed) to the area where ordinary metal plastically deforms at the use temperature, that is, at least the living body temperature (around 37 ° C.). .

The preferred composition of the superelastic alloy is 49
Ti-Ni alloy of -58 atomic% Ni, 38.5-41.
5 wt% Zn Cu-Zn alloy, 1-10 wt% X C
u-Zn-X alloy (X is Be, Si, Sn, Al, G
a), a superelastic body such as a 36-38 atomic% Al-Ni-Al alloy. Among them, particularly preferred is the above-mentioned Ti-Ni alloy.

The second wire B is a wire having flexibility, and the material of the second wire B is not particularly limited. Various plastics and various metals can be used. It is composed of a material having greater rigidity, especially a metallic material. Thereby, a wire main body excellent in operability and kink resistance can be obtained without increasing the diameter of the second wire B.

The outer diameter of the second wire B can be made larger than the outer diameter of the first wire A in order to improve the operability and the kink resistance (see the second wire B in FIG. 1). ). In this case, the second portion of the portion encapsulated by the connection member 12
The outer diameter of the wire B is to improve the ease of connection.
It is preferable that the outer diameter of the portion of the first wire A to be covered by the connection member 12 is equal to that of the first wire A.

Preferred examples of the metal material used for the second wire B include metal materials such as stainless steel and piano wire. Among them, particularly preferred is stainless steel having excellent rigidity.

The connecting member 12 is flexible and has a first
Has an opening 122 through which the wire A is inserted and an opening 123 through which the second wire B is inserted. The opening 122 and the opening 123 are electrically connected to each other and have a tubular shape.

As described above, by making the connecting member 12 into a tubular shape, the connecting process between the first wire A and the second wire B becomes easy, and the rigidity in the circumferential direction becomes uniform.

The constituent material of the connecting member 12 is not particularly limited, and various plastics and various metals can be used similarly to the first wire A and the second wire B. In particular, the connecting member 12 is preferably made of a material whose stiffness is larger than the stiffness of the first wire A, and is more preferably made of the same or similar material as the second wire B. preferable.

Here, when the rigidity of the connecting member 12 is equal to or less than the rigidity of the first wire A, the rigidity of the portion of the connecting member 12 is equal to the rigidity of the first wire A encapsulated in the connecting member 12. And the rigidity of the second wire B. In such a case,
A large difference in rigidity between the first wire A and the second wire B occurs at the boundary 124 between the first wire A and the second wire B encapsulated in the connection member 12.

On the other hand, when the rigidity of the connecting member 12 is larger than the rigidity of the second wire B, the rigidity of the portion of the connecting member 12 depends on the rigidity of the connecting member 12 itself. In such a case, there is no difference in rigidity at the portion of the connection member 12, but
The boundary between the opening 122 and the first wire A and the opening 12
A large difference in rigidity occurs at the boundary between the third wire and the second wire B.
Since stress concentration occurs in a portion where such a large difference in rigidity is generated, mechanical energy is not smoothly transferred, and operability and kink resistance are impaired.

Preferred compositions of the superelastic alloy used for the connection member 12 include the Ti—Ni alloy and the C
u-Zn alloy, the Cu-Zn-X alloy (X is Be,
(At least one of Si, Sn, Al, and Ga), the Ni-Al alloy, and the superelastic body such as the stainless steel. In particular, as the connection member 12, the connection member 12
In order to continuously form a value equal to or less than the stiffness value of the first wire A from the stiffness value of the second wire B, a material having the same stiffness as the second wire B is preferable. This is because the rigidity value can be easily reduced by processing the connection member 12.

The connecting member 12 is made of the same or similar metal as the first wire A or the second wire B in order to easily connect the first wire A and the second wire B. Is preferred. In particular, it is preferable to use the same or similar metal as the second wire B.

The thickness between the inner surface and the outer surface of the tubular connecting member 12 is 0.02 to 0.06 in that the necessary and sufficient strength can be secured and the operability can be improved.
mm, more preferably 0.03 to 0.05 mm.

In the present invention, the rigidity of the connecting member 12
In order to gradually and continuously change the rigidity of the wire A from the rigidity of the second wire B, the connecting member 12 is subjected to a predetermined processing. Specifically, as shown in (1) and (2) of FIG. 2, a spiral slit or groove may be formed in the enclosing portion 121 of the connecting member 12 enclosing the first wire A. preferable. Such slits and grooves are
It has a function of reducing the rigidity of the connection member 12.

As shown in FIGS. 2 (3) to (5), the covering portion 1 of the connecting member 12 for covering the first wire A is provided.
For example, a slit 21 of a horizontal groove or a horizontal line ((3) in FIG.
Vertical slits and vertical slits (see (4) in FIG. 2),
A lattice-shaped groove (see (5) in FIG. 2) can be formed.

Each groove can be formed on the outer surface and / or the inner surface of the enclosing portion 121. Although not shown, the groove and the slit can be formed together. Further, it is preferable that the groove and the slit do not straddle the boundary 124 between the first wire A and the second wire B. Forming a groove or a slit in the boundary portion 124 causes a reduction in rigidity at the boundary portion 124, which may cause a kink.

These grooves and slits change the rigidity of the portions in accordance with their intervals and pitches. More specifically, as described above, a material having the same rigidity as the second wire B is used for the connection member 12, and as shown in FIGS. 1 to 3, the first wire A side (the distal end side) of the connection member 12 About
The rigidity value of the connecting member 12 enclosing the first wire A is reduced by forming a groove or a slit so that the interval or the pitch becomes denser and the interval or the pitch becomes coarser toward the boundary 124. The stiffness value of the first wire A can be continuously changed from the stiffness value of the second wire B.

Needless to say, the pattern of forming the grooves and slits is not limited to the illustrated one.

Further, the tip portion 111 of the first wire A
Although not particularly limited, it is more preferable that an X-ray contrast material 112 is sealed in the distal end portion 111 and that a smooth coating with a polymer material such as a synthetic resin is further applied so as to have a rounded distal end. . X-ray contrast material 1
By using 12, the position of the distal end of the guide wire 1 can be monitored and confirmed under X-ray fluoroscopy. Also, by the coating portion 113 made of a polymer material,
The guide wire 1 can prevent the inner wall of the blood vessel from being lost due to the contact with the blood vessel wall.

The first wire A preferably has an outer diameter gradually decreasing toward the tip. By using the tapered material, the X-ray contrast material 112
, Or a coating portion 113 made of a synthetic resin or the like, the tip portion 111 can maintain a constant outer diameter. The operation of inserting such a guidewire 1 into the blood vessel from the distal end side and reaching the target site can be performed safely and flexibly in a complicated blood vessel shape such as a curved or branched blood vessel.

As the X-ray contrast material 112, for example, a wire (for example, a metal wire such as gold or platinum) of an X-ray opaque material can be wound in a coil shape and sealed.

The polymer material constituting the coating portion 113 includes polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polyurethane, polystyrene, polycarbonate, fluororesin (PTFE, ETFE, etc.), silicone rubber, and various other materials. Elastomers or composite materials thereof are preferably used. In particular, a wire having the same or lower flexibility and flexibility as the first wire A is preferable.

Further, it is preferable that a layer (not shown) made of a hydrophilic polymer substance having lubricity in a wet state is formed on the outer peripheral surface of the coating portion 113. Thereby, when inserting the guidewire 1, friction is reduced, the insertion can be performed smoothly, and operability and safety are improved.

Examples of the hydrophilic polymer substance include natural polymer substances (eg, starch, cellulose, tannin / nigin, polysaccharide, protein) and synthetic polymer substances (PVA). System, polyethylene oxide system, acrylic acid system, maleic anhydride system, phthalic acid system, water-soluble polyester, ketone aldehyde resin, (meth) acrylamide system, vinyl heterocyclic system, polyamine system, polyelectrolyte, water-soluble nylon system, Glycidyl acrylate).

Among these, particularly, cellulosic polymer substances (for example, hydroxypropylcellulose),
Polyethylene oxide polymer (polyethylene glycol), maleic anhydride polymer (eg, maleic anhydride copolymer such as methyl vinyl ether maleic anhydride copolymer), acrylamide polymer (eg, polydimethyl Acrylamide), water-soluble nylon (for example, AQ-nylon P-70 manufactured by Toray)
Alternatively, derivatives thereof are preferable because a low friction coefficient can be stably obtained in blood. These details are described in the specification of Japanese Patent Application No. 7-270519.

Further, it is preferable that the second wire B is subjected to a treatment for suppressing friction generated by contact with the inner wall of the catheter used simultaneously with the guide wire 1. Specifically, a material having a low coefficient of friction with respect to the material of the catheter inner wall (for example, a fluorine-based resin such as polytetrafluoroethylene, silicone, or the like) is provided on the proximal portion (base) 131 where the second wire B contacts the inner wall of the catheter. Etc.) may be coated. By suppressing the friction, the operability of the second wire B in the catheter can be maintained without being impaired.

The first wire A, the connecting member 12, the second
The diameter of each wire B is not particularly limited, but when used for insertion of a PTCA catheter, each diameter (average) is 0.25 to 0.65 mm (0.010 to 0.02 mm).
5 inches), preferably 0.36 to 0.4
More preferably, it is about 5 mm (0.014 to 0.018 inch).

The connection between the first wire A and the second wire B at the connection member 12 is not particularly limited, but the connection member 12 is welded to the first wire A and the second wire B, respectively. It is preferable to fix by this. For example, as shown in FIG. 3, an end face of the first wire A cut at a predetermined angle (θ) with respect to a plane whose normal line is the axis of both wires A and B and the end face of the first wire A coincides with the end face. Then, the end face of the second wire B similarly cut is brought into contact with the inside of the connection member 12 to perform connection. Here, the angle θ
May be θ ≦ 90 degrees, preferably 0 <θ ≦ 45 degrees, and more preferably 0.5 ≦ θ ≦ 20 degrees. The reason is that the first wire A and the second wire B
This is because the change in rigidity at the contact end face with the fin can be further reduced, and excellent kink resistance can be obtained.

The connection method is not particularly limited, and may be a conventional method such as spot welding using a laser. The welding location may be a portion including, for example, the distal end side and the proximal end side of the boundary portion 124, and is not particularly limited. Welding may be performed on the entire connection member 12 or may be performed only on the periphery of the boundary portion 124 (excluding portions where grooves and slits are formed). Further, the end surfaces of both ends of the connection member 12 may be bonded and fixed. Further, if the connection is made by using the groove or the slit formed on the inner surface, there is an advantage that the joining force is improved. As the thickness of the connecting member 12 becomes smaller to some extent, the connecting material is more easily melted, and the weldability is improved. Therefore, the thickness of the connection member 12 is preferably in the range described above.

When the connecting member 12 is made of stainless steel, which is a material having high rigidity, its thickness can be reduced, and the connectivity, particularly the weldability with the first wire A, is improved. Also, a second wire B made of stainless steel
On the other hand, when the connecting members 12 are made of the same type of stainless steel, they have excellent weldability due to the same composition.

The connection can also be made by caulking. The caulking process can be easily performed by strongly pushing the first wire A and the second wire B into the connecting member 12 from opposite sides, and pressing the boundary 124 from the outside. This caulking process can be used together with the welding. In order to enhance the connectivity by the caulking process, it is preferable that the connection end surfaces of both wires A and B are inclined as described above. Due to the inclination of the end surfaces, when the two wires A and B are pressed so that they come into contact with each other, a deviation occurs in the opposite direction with respect to the axis of the two wires A and B at the boundary portion 124, thereby causing the projecting portion Is formed, and the connecting member 1 is formed.
It can be swaged by the expansion force from the inside of 2. The inclination of the connection end surfaces of the wires A and B in this manner also has an effect of reducing a change in rigidity at the boundary 124.

FIG. 3 shows a connection procedure of another connection method. FIG. 1 shows the procedure of butt seam welding, which is an example of butt resistance welding.

In the procedure, a first wire A and a second wire B set in a butt welding machine (not shown) are shown. The connection member 12 is fitted on the distal end side of the first wire A in advance.

In the procedure, the first wire A and the second wire B are connected to the end face on the base end side of the first wire A and the second wire B while applying a predetermined voltage by a butt welding machine. Is brought into pressure contact with the end face on the tip side of the. Due to this pressure contact, a molten layer is formed at the contact portion, and the first wire A
And the second wire B are firmly connected.

In the procedure, the protruding portion of the connection portion deformed by the pressure contact is deleted so that the connection member 12 can cover the connection portion.

Next, the connection portion is covered with the connection member 12 in the procedure. In the procedure, the connection member 12 is fixed to the first wire A and the second wire B at its ends by a predetermined adhesive 20.

Thus, in addition to the spot welding,
The first by butt seam welding (butt resistance welding)
And the second wire B can be connected.

The present invention is not limited to the above connection methods, but may be, for example, brazing (soldering) or adhesive bonding.

The operability and the kink resistance of the guide wire 1 as described above are clarified by the bending rigidity measurement described below.

FIG. 4 shows a bending stiffness measuring point near the connecting member 12 of the guide wire 1 of the present invention and a bending stiffness measuring point near the connecting member 12 of the guide wire 10 according to the comparative example of the present invention.

Here, the first wire used for the guide wire 1
The wire A is made of the above-mentioned Ti—Ni alloy, and the connecting member 1
The second and second wires B are made of the stainless steel.
The guide wire 10 of the comparative example is the same as the guide wire 1 except that no slit is formed in the connection member 12.

The bending rigidity measurement points are indicated by arrows 1 to 1 shown in FIG.
14. Arrows 1 to 13 are set at intervals of 5 mm, and only arrow 14 indicates a bending rigidity measurement point of the second wire B.

The measurement of the bending stiffness was performed using guide wires 1 and 10
, An arrow indicating section (arrows 1 to 14) serving as a measurement point
A fulcrum for supporting the guidewires 1 and 10 was provided at a position 1/2 inch before and after the above, and the load required to press the arrow indicating portion by 2 mm was measured.

Arrows 1 and 2 of the guide wire 1 indicate locations where the bending stiffness of the first wire A is measured, and arrows 3 to 10 indicate the bending stiffness of the connecting member 12 enclosing the first wire A in which a slit is formed. An arrow 11 indicates a bending stiffness measurement point where no slit is formed in the connection member 12 enclosing the first wire A, an arrow 12 indicates a boundary portion 124,
Arrow 13 indicates a bending stiffness measurement location enclosing the second wire B, and arrow 14 indicates a bending stiffness measurement location of the second wire B portion (thick diameter portion).

Arrows 1 and 2 of the guide wire 10 indicate locations where the bending stiffness of the first wire A is measured.
Numeral 11 indicates a bending rigidity measuring point of the connection member 12 having no slit and enclosing the first wire A, and an arrow 12 indicates a boundary 1
24, arrow 13 indicates a bending stiffness measurement location enclosing the second wire B, and arrow 14 indicates a bending stiffness measurement location of the second wire B portion (portion having a large diameter).

Table 1 shows the measured values of the bending stiffness of the guide wires 1 and 10 measured at the arrow indicating portions (arrows 1 to 14).

[0066]

[Table 1]

FIG. 5 is a graph showing the measured values of the bending stiffness shown in Table 1. The vertical axis of the graph is the bending rigidity value (g), and the horizontal axis is the above-mentioned arrow 1 which is the bending rigidity measurement point.
14 are shown.

The following can be recognized from the measured bending stiffness values. (1) Measurement with guide wire 1 By forming the slit so that the pitch of the slit changes from dense (arrow 3) to coarse (arrow 10), the measured value at arrows 3 to 10 can be measured using the first wire A From the bending stiffness value of the connecting member 12 without the slit enclosing the first wire A to the bending stiffness value. The bending stiffness value likewise changes continuously up to the site. This shows that when the guide wire 1 is bent, a smooth curved state without kink can be obtained.

(2) Measurement with guide wire 10 There is a large difference in bending stiffness between arrow 2 and arrow 3.
Thereby, it turns out that when the guide wire 10 is bent, a sharp angle is easily generated. The above tendency is the same for the torsional rigidity of the wire.

The same measurement was performed by replacing the slit formed in the connecting member 12 with the groove, and the same result was obtained.

As described above, the guide wire 1 of the present invention
The rigidity of the connection member 12 can be continuously changed from the rigidity of the first wire A to the rigidity of the second wire B. That is, in the connecting member 12 of the guide wire 1, a large difference in rigidity is generated in the connecting member 12, so that a large difference in rigidity is prevented, and stress concentration can be dispersed. This means that the operability and the kink resistance of the guidewire 1 are improved as compared with the guidewire 10.

FIGS. 6 and 7 are views showing a use state when the guide wire 1 of the present invention is used for PTCA operation.

6 and 7, reference numeral 4 denotes an aortic arch, reference numeral 5 denotes a right coronary artery of the heart, reference numeral 6 denotes an opening of the right coronary artery,
Reference numeral 7 denotes a blood vessel stenosis part. Reference numeral 3 denotes a guiding catheter for reliably guiding the guide wire 1 from the femoral artery to the right coronary artery, and reference numeral 21 denotes a balloon for expanding a stenosis having a balloon that can be expanded and contracted at a distal end portion 111 of the guide wire 1. It is a catheter.

As shown in FIG. 6, the distal end of the guide wire 1 is projected from the distal end of the guiding catheter 3 and inserted into the right coronary artery 5 through the opening 6 in the right coronary artery. Further, the guide wire 1 is advanced, inserted into the right coronary artery from the distal end, and stopped at a position where the distal end has passed the vascular stenosis 7. Thereby, the passage of the balloon catheter 2 is secured.

Next, as shown in FIG.
The distal end of the balloon catheter 2 inserted from the proximal end of the balloon is projected from the distal end of the guiding catheter 3, further advanced along the guide wire 1, inserted into the right coronary artery 5 from the right coronary artery opening 6, and inserted into the balloon. Stops when it reaches the position of the vascular stenosis 7.

Next, a balloon expansion fluid is injected from the proximal end side of the balloon catheter 2 to expand the balloon 21 and expand the blood vessel stenosis portion 7. By doing so, the deposits such as cholesterol adhered and deposited on the blood vessels of the blood vessel stenosis part 7 are physically pushed out, and the obstruction of blood flow can be eliminated.

Although the guide wire according to the present invention has been described based on the illustrated embodiments, the present invention is not limited to these embodiments. For example, the first wire A and the second wire B constituting the wire main body may be constituted by any of a solid member and a hollow member, and the constituent material is the above-described superelastic alloy or piano. Wire, stainless steel, other metal materials such as tungsten, for example, polyimide, polyester,
It may be composed of various resin materials such as polyolefin (polypropylene, polyethylene), fluororesin, polyurethane and the like. Further, the wire main body may be formed of a laminate in which a plurality of layers having different materials or physical characteristics are laminated.

[0078]

As described above, according to the guide wire of the present invention, a groove and / or a slit are provided at a position on the distal end side of the boundary between the first wire and the second wire of the connecting member. Is formed, a continuous change can be given to the rigidity of the connection member.

In particular, said grooves and / or slits
If the connection member is formed so as to be denser toward the distal end, the rigidity can be continuously increased from the distal end of the first wire to the boundary between the first wire and the second wire.

Further, the second wire is made of a metal material having higher rigidity than the first wire, and the connecting member is made of the same or similar material as the second wire, and the rigidity of the connecting member has a gradient. If given, the stiffness can be increased continuously from the first wire to the second wire.

Further, the first wire is made of a superelastic metal and the second wire is made of stainless steel, so that the first wire has a highly flexible distal end and a rigidly rich proximal end, A guide wire having a gentle change in rigidity can be configured.

Further, the first wire and the connecting member, and
By fixing the second wire and the connection member by welding, respectively, it is possible to enhance the bonding force between the first wire and the second wire. In this case, excellent welding properties can be obtained by selecting the materials of the two wires and the connecting member.

Further, if the connection end face between the first wire and the second wire is formed at a predetermined angle with respect to a plane whose normal line is the axis of both wires, the rigidity change at the boundary can be reduced. It is possible to further relax and further enhance the bonding force between the first wire and the second wire.

As described above, according to the present invention, the difference in rigidity between the first wire and the second wire is determined by selecting a suitable tubular connecting member and forming a desired groove or slit in the connecting member. By doing so, the stress can be dispersed by converting into a number of small differences in rigidity in the connection member. That is, the present invention can provide a guidewire that can smoothly transfer mechanical energy from the base end to the distal end, and is excellent in operability and kink resistance.

[Brief description of the drawings]

FIG. 1 is an explanatory view showing an embodiment of a guide wire according to the present invention.

FIG. 2 is an explanatory view showing an example of a groove or a slit provided in a guide wire connecting member of the present invention.

FIG. 3 is an explanatory view showing an example of a method for connecting a guide wire according to the present invention.

FIG. 4 is an explanatory diagram showing bending stiffness measurement points.

FIG. 5 is a graph showing measurement results of bending stiffness.

FIG. 6 is a schematic diagram for explaining a usage example of the guide wire of the present invention.

FIG. 7 is a schematic diagram for explaining an example of using the guide wire of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Guide wire 111 Tip part 112 X-ray contrast material 113 Coating part 12 Connection member 121 Encapsulation part 122 Opening 123 Opening 124 Boundary part 131 Hand part (base) 2 Balloon catheter 3 Guiding catheter 4 Aortic arch 5 Right coronary artery 6 right coronary artery opening 7 vascular stenosis 10 guide wire 20 adhesive 21 balloon A first wire B second wire θ angle

Claims (7)

[Claims] 1. A flexible first member disposed on a distal end side.
And a second wire disposed closer to the proximal end than the first wire and having a greater rigidity than the first wire; and a tubular connecting the first wire and the second wire. A guide having a connection member, wherein the connection member has a groove and / or a slit formed at a position on the distal end side of a boundary between the first wire and the second wire. Wire. 2. A flexible first member disposed on the distal end side.
And a second wire disposed closer to the proximal end than the first wire and having a greater rigidity than the first wire; and a tubular connecting the first wire and the second wire. A connection member, wherein the connection member forms a groove and / or a slit at a position on the distal end side from a boundary between the first wire and the second wire, and A guide wire, wherein a rigidity near an end portion is configured to change continuously along a longitudinal direction of the wire. 3. The guide wire according to claim 1, wherein the groove and / or the slit are formed so as to be denser toward a distal end of the connection member. 4. The device according to claim 1, wherein the second wire is made of a metal material, and the connection member is made of the same or similar material as the second wire. Guide wire. 5. The guidewire according to claim 4, wherein the first wire is made of a superelastic metal, and the second wire is made of stainless steel. 6. The guide wire according to claim 1, wherein the first wire and the connection member, and the second wire and the connection member are fixed by welding, respectively. 7. A connection end face between the first wire and the second wire is inclined at a predetermined angle with respect to a plane whose normal line is the axis of both wires. The guidewire according to any one of the above.